Leishmaniasis

This research aims to understand how eosinophils, a type of white blood cell, become activated and their role in immune responses. Eosinophil counts often increase due to allergies, asthma, parasitic infections, autoimmune conditions, or rarely, tumors. Elevated eosinophil levels, called eosinophilia, usually cause no symptoms but can sometimes lead to swelling, itching, allergic lung problems, heart disease, or nerve damage. Participants with eosinophil counts over 750ml or abnormal eosinophil buildup in skin or tissues, aged 1 to 100 years, will undergo clinical evaluations including medical history, exams, and blood tests. Additional testing may include studies of eyes, lungs, skin, bone marrow, nerves, or heart depending on symptoms and age. This is an observational study without experimental treatments patients needing therapy will get standard care. Some participants may also undergo bone marrow biopsy, genetic testing, or leukapheresis for adults for research purposes. During the study, participants will donate blood samples for laboratory studies and may have annual follow-ups with exams and blood tests to track eosinophil levels and condition changes. Researchers will collect samples like blood, bone marrow, tissue, and body fluids to study disease mechanisms, biomarkers, and treatment responses. The study will monitor clinical and immunological responses to therapy and evaluate family members to explore genetic causes of eosinophilia. The main goal is to better understand eosinophilic disorders and improve diagnosis and treatment options.

Researchers are evaluating the safety and effectiveness of arnica tincture as a topical treatment for localized cutaneous leishmaniasis CL, a parasitic skin disease caused by Leishmania species. The study compares arnica tincture to the current local treatment with intralesional pentavalent antimonials. This trial builds on prior research showing positive results for arnica tincture in Colombia and aims to offer a potentially safer option with fewer systemic side effects. This is a randomized, single-blind clinical trial including two treatment groups. One group will apply arnica tincture topically three times a day for 30 days, while the other will receive intralesional injections of pentavalent antimonials once weekly for five weeks, dosed by lesion size. Both treatments target localized skin lesions caused by CL, and the study evaluates the safety and healing outcomes of these approaches. Participants will be assessed through clinical examinations of their lesions at regular intervals up to 90 days post-treatment to measure healing rates. Safety will be monitored by recording adverse effects. Follow-up visits will continue for more than three months to observe final healing status and any treatment-related issues. The trial aims to provide data on both effectiveness and side effects to inform future treatment choices for CL patients.

Researchers are evaluating the effectiveness of intralesional ciprofloxacin 0.2% solution compared to intralesional sodium stibogluconate SSG 10% intravenous solution for treating cutaneous leishmaniasis. This phase 2 randomized parallel groups clinical trial aims to compare these two local injection therapies for patients with cutaneous leishmaniasis lesions. Participants are divided into two groups receiving either weekly intralesional injections of ciprofloxacin at a dose of 2 mgcm2 or sodium stibogluconate at 1 mgcm2. Both treatments are given once weekly for up to six weeks. Each lesion is injected using a fine insulin needle until the base is blanched, with volumes ranging from 0.2 to 4.0 ml per lesion depending on size. Treatment stops early if lesions are cured before six weeks. During the study, each lesion is followed for up to 90 days or until it is cured. Patients attend weekly visits for injections and lesion assessments. Researchers measure the cure rate from enrollment to the end of treatment within the 90-day follow-up. Safety and response are closely monitored throughout the study period.

Researchers are conducting a prospective cohort study to develop a tool that predicts relapse in patients with visceral leishmaniasis VL from endemic regions in Ethiopia. The study aims to identify factors that influence prognosis by thoroughly assessing clinical and laboratory data before and during treatment. This effort seeks to improve patient care, reduce death and illness rates, and enhance monitoring for those at risk of VL relapse. The study involves comprehensive clinical and laboratory evaluations of confirmed VL patients. These assessments include a wide range of parameters such as immune markers, blood tests including coagulation profiles and cultures, and clinical conditions like sepsis and comorbidities. The goal is to create prognostic tools of varying complexities suited to different healthcare settings, which will help stratify patients into high and low risk groups for relapse, treatment failure, and mortality. Participants will undergo detailed follow-up throughout treatment to collect data that helps identify risk factors for relapse, treatment failure, and death. The main outcomes measured include the development of the prognostic tool and identification of key risk factors by December 2026. This observational study monitors patients without any intervention, focusing on improving understanding and management of VL through ongoing clinical and laboratory evaluations.

This research focuses on patients with active Leishmania infection, aiming to diagnose and classify the infection while studying the natural history and host factors contributing to resistant or relapsing disease. The study also investigates the host immune response before and after therapy to better understand disease diagnosis, progression, and treatment response. Patients receive optimal clinical care while contributing valuable samples for laboratory research on leishmanial infections. Participants receive species-based treatment appropriate to their infection. Standard evaluations include biopsies to obtain parasite and host tissue. Following treatment, patients have follow-up visits at 3 months, 6 months remote check-in via photo, telephone, or telehealth, and 12 months to monitor disease progression and treatment response. Additional visits may be scheduled as needed based on clinical status. Samples such as blood, lesion swabs, mucosal swabs, microbiopsies, and skin biopsies are collected for research purposes throughout the study. During the study, participants undergo physical examinations and provide various biological samples for research evaluation. The study tracks clinical and immunologic responses over time, with long-term follow-up beyond one year if clinically necessary. Research measurements include immune workups, genomic data collection, and clinical documentation of disease course to assess treatment safety and effectiveness. Participants can also be evaluated remotely if their physicians can submit required specimens. The total participation duration typically extends to one year post-treatment, with possible annual follow-ups thereafter.

Researchers are evaluating the safety, tolerability, and effectiveness of adding metformin to standard multidrug therapy MDT for patients newly diagnosed with multibacillary leprosy. This double-blind, placebo-controlled Phase 2 trial aims to see if metformin can reduce leprosy reactions, nerve damage, and corticosteroid use while assessing immunological responses. The study is supported by the Leprosy Research Initiative and conducted in Indonesia with participants aged 18 to 65. Participants will be randomly assigned to receive either metformin or a placebo once daily. Metformin dosing starts at 500mg for two weeks, then increases to 1000mg for 22 weeks, alongside 48 weeks of standard MDT. The placebo group receives matching tablets to maintain blinding. The trial plans to enroll 166 patients to compare clinical outcomes between the two groups. During the 48-week study, participants will be regularly monitored for leprosy reactions, adverse events, nerve function, corticosteroid use, and quality of life through clinical assessments and questionnaires. The primary outcomes include the proportion of patients experiencing leprosy reactions and adverse events within specified timeframes. Secondary outcomes focus on reaction severity, timing, frequency, and impact on daily living. Safety and tolerability will also be closely observed throughout the study period.

Researchers are evaluating the feasibility of using thermotherapy TT to treat cutaneous leishmaniasis CL in health centers located in the Sodo and South Sodo districts of Ethiopia. The study aims to determine if thermotherapy is practical, acceptable, and suitable in these settings, and to assess its effectiveness compared to health centers that do not offer thermotherapy. Patients in non-thermotherapy centers will be monitored for up to three months before referral to centers providing TT treatment. Thermotherapy is administered using the ThermoMed device, which heats the affected skin area to 50C for 30 seconds. Treatment may be given up to two times depending on patient response if no improvement is seen at week 4, a second dose is given if there is some response at week 4 but incomplete healing by week 8, a second dose may be administered then. The study involves training primary healthcare staff and health extension workers to diagnose and manage CL and to deliver the thermotherapy treatment. This project is conducted in phases, including development of training materials, piloting in two health centers with 20 patients, and broader implementation in additional centers with up to 165 patients. Participants will be screened and recruited at nearby health centers and monitored regularly with follow-up visits every four weeks until day 90. Digital photos and skin scrape samples will be collected for diagnosis confirmation. The study also uses focus groups and interviews to assess feasibility, acceptability, and appropriateness of integrating TT into primary care. Researchers will evaluate treatment success, diagnostic accuracy of healthcare staff, and patient adherence to treatment protocols. Patients successfully treated will be checked again at day 180 to monitor for any relapse of lesions.

Vector-borne diseases, caused by bites from infected mosquitoes, flies, fleas, ticks, or other blood-feeding insects, result in nearly one million deaths annually and are increasing, especially in Southeast Asia. In Cambodia, these diseases may account for about 10 percent of fevers, but many cases go undiagnosed. This research aims to better understand the range of febrile illnesses by using advanced metagenomic sequencing to identify pathogens in affected individuals. Participants include people aged 2 months and older who have a fever of at least 38 degrees Celsius or are diagnosed with a concerning pathogen. Close contacts of infected individuals may also join. The study collects blood samples, and for those with respiratory symptoms, nasal swabs. Participants share information on their age, sex, health history, and recent travel. If a highly transmissible or virulent pathogen is found, follow-up samples and testing of close contacts are performed to deepen understanding of disease spread. During the study, participants undergo screening with medical history review and physical assessments such as weight for children. They complete questionnaires and provide biological samples for pathogen identification. Optional follow-up samples may be collected within 1 to 2 weeks and again at 3 months after enrollment. Researchers measure pathogen sequences and immune responses to vector saliva proteins. The study continues through July 2027, aiming to improve knowledge of febrile diseases in Cambodia.

This research focuses on patients with filarial infections, which are caused by parasitic worms transmitted through mosquito bites. The study aims to explore the immune systems response to these infections, including how people become susceptible, develop disease, and respond to treatment. The study includes patients diagnosed with or suspected of having infections such as Wuchereria bancrofti, Brugia malayi, Onchocerca volvulus, and Loa loa, among others. The research is observational and involves standard medical care without experimental diagnostics or treatments. Participants receive standard treatments like diethylcarbamazine or ivermectin depending on the infection type. Diagnostic tests include routine evaluations and may involve lung, skin, or heart assessments. Some patients might undergo skin biopsies or bronchoalveolar lavage if medically necessary. Additional research procedures include extra blood draws to study immune cells, urine collections, skin allergy tests, and leukapheresis to collect white blood cells in adults. During the study, participants undergo frequent and detailed follow-up evaluations including physical exams and blood tests. Researchers monitor immune responses and clinical outcomes over time, collecting blood and serum samples for laboratory studies. The main goal is to identify markers of infection, treatment responses, and immune regulation over a 10-year period. This long-term observation helps understand disease progression and treatment effects while ensuring patients receive optimal clinical care.

Researchers are studying Leishmaniasis, a parasitic infection, to identify specific biomarkers that could improve blood tests for detecting the disease. The study aims to find biomarkers that do not cross-react with other infections such as Chagas, tuberculosis, leprosy, or malaria. It also examines the Antigen Recognition Patterns ARPs of Leishmania infection and whether these patterns apply to different strains from Italy, Sudan, and other regions. The study involves analyzing stored and newly collected blood and serum samples from patients with confirmed Leishmaniasis, uninfected individuals, and those with other infections. Researchers use a specialized diagnostic test called Western blot to examine different protein fractions from Leishmania strains. They identify specific immunogenic proteins through laboratory techniques including mass spectrometry. Participants contribute blood samples that are tested and analyzed for biomarkers and ARPs. The study reviews these patterns at baseline to understand cross-reactions with other diseases. Samples come from multiple groups, including Leishmaniasis patients, healthy controls, and individuals with other infections. The research is observational with no assigned treatments, and participation involves providing samples and medical data. The study is expected to continue until November 2026.